Granger Dane, Hilgart Heather, Misner Lori, Christensen Jaime, Bistodeau Sarah, Palm Jennifer, Strain Anna K, Konstantinovski Marja, Liu Dakai, Tran Anthony, Theel Elitza S
Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
Minnesota Department of Health, St. Paul, Minnesota, USA.
J Clin Microbiol. 2017 Jul;55(7):2127-2136. doi: 10.1128/JCM.00580-17. Epub 2017 Apr 26.
Serologic evaluation for Zika virus (ZIKV) infection currently includes an initial screen using an anti-ZIKV IgM antibody capture enzyme-linked immunosorbent assay (MAC-ELISA) followed by supplemental testing of specimens with nonnegative results by a plaque reduction neutralization test (PRNT). We compared the performance characteristics of three ELISAs for the detection of IgM class antibodies to ZIKV, including the Centers for Disease Control and Prevention (CDC) Zika MAC-ELISA, the InBios ZIKV MAC-ELISA, and the Euroimmun anti-Zika Virus IgM ELISA. Additionally, we present our initial experiences with ZIKV serologic testing from a national reference laboratory perspective. Using both retrospectively and prospectively collected specimens from patients with possible ZIKV infection, we show that the CDC and InBios MAC-ELISAs perform comparably to each other, with positive agreement, negative agreement, and interrater kappa values ranging from 87.5% to 93.1%, 95.7% to 98.5%, and 0.52 to 0.83, respectively. In contrast, comparison of the Euroimmun ZIKV ELISA to either the CDC or InBios MAC-ELISAs resulted in positive agreement, negative agreement, and interrater kappa values ranging from 17.9% to 42.9%, 91.7% to 98.6%, and 0.10 to 0.39, respectively. Among the 19 prospective samples submitted for PRNT, nine were negative, eight specimens had neutralizing antibodies to a flavivirus (unable to be identified), and one sample each was confirmed for ZIKV or dengue virus infection. This study highlights the ongoing challenges associated with serologic diagnosis of ZIKV infection. Although the availability of a commercial serologic test for ZIKV has greatly expanded the national capacity for such testing, the need to further characterize and improve these assays, particularly with regard to specificity, remains.
寨卡病毒（ZIKV）感染的血清学评估目前包括使用抗寨卡病毒IgM抗体捕获酶联免疫吸附测定（MAC - ELISA）进行初步筛查，随后对斑贴减少中和试验（PRNT）结果为非阴性的标本进行补充检测。我们比较了三种用于检测抗寨卡病毒IgM类抗体的ELISA的性能特征，包括疾病控制与预防中心（CDC）寨卡MAC - ELISA、InBios寨卡病毒MAC - ELISA和Euroimmun抗寨卡病毒IgM ELISA。此外，我们从国家参考实验室的角度介绍了寨卡病毒血清学检测的初步经验。通过回顾性和前瞻性收集可能感染寨卡病毒患者的标本，我们发现CDC和InBios MAC - ELISA的表现相当，阳性一致性、阴性一致性和组间kappa值分别为87.5%至93.1%、95.7%至98.5%和0.52至0.83。相比之下，将Euroimmun寨卡病毒ELISA与CDC或InBios MAC - ELISA进行比较，阳性一致性、阴性一致性和组间kappa值分别为17.9%至42.9%、91.7%至98.6%和0.10至0.39。在提交进行PRNT的19份前瞻性样本中，9份为阴性，8份标本具有针对黄病毒的中和抗体（无法鉴定），1份样本分别被确认为寨卡病毒或登革病毒感染。这项研究突出了寨卡病毒感染血清学诊断面临的持续挑战。尽管寨卡病毒商业血清学检测的可用性极大地扩展了国家进行此类检测的能力，但仍需要进一步表征和改进这些检测方法，特别是在特异性方面。
